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U2 Knee Modular Disposable Trial
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2104-2115
Identity
- Trade Name
- U2 Knee Modular Disposable Trial EUDAMEDU2™ Knee FDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Device Name
- Femoral trial set, #1.5, left EUDAMEDFDA UDI
- Model / Reference
- 2104-2115 EUDAMEDFDA UDI
- Description
- Femoral trial set, #1.5, left FDA UDI
Identifiers
- Catalog Number
- 2104-2115 FDA UDI
- Primary DI / UDI-DI
- 04711605578943 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711605578943 EUDAMED
- 510(k) Number
- K120507 FDA UDIK131116 FDA UDIK131864 FDA UDIK132752 FDA UDIK140073 FDA UDIK140075 FDA UDIK150829 FDA UDIK150832 FDA UDIK152430 FDA UDIK161360 FDA UDIK161705 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Knee femur prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
U2 Knee Modular Disposable Trial by United Orthopedic Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711605578943 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 18f27d72-734e-44b7-aebb-e75cc333c996 61 fields · synced Jul 11, 2026
- FDA UDI e26cefd3-f94a-423b-a7dd-786ad2b5d9f3 37 fields · synced May 30, 2026